1 Introduction

This chapter contains the following topics:

Overview
What's New
What Can I Do Using Oracle Health Sciences Network?

1.1 Overview

Oracle Health Sciences Network (HSN) is a new SaaS services offering for both healthcare provider and pharmaceutical customer organizations. It brings together multiple customer organizations under a single cloud based, Oracle hosted, business network, thus allowing them to exchange information and (or) business services using HSN applications such as Protocol Validator and Patient Recruiter (PVPR).

Each organization participating in HSN can either offer or consume both information (such as finding cohorts to recruit into study) or business process services (such as identifying, reserving and recruiting patients into a clinical trial) to other network participants.

Any organization offering any service in HSN is typically referred to as a provider organization in HSN. Similarly, an organization may not necessarily provide these services in the network, but rather simply may avail services provided by other organizations. So any organization consuming one or more services from another organization in HSN is referred to as a sponsor (or consumer) organizations in HSN. In certain cases, a single organization may act as both a consumer and provider of HSN services simultaneously.

Oracle Health Sciences Network comprises of the following 3 services:

Data Management Cloud Service (DM): Lets customers, for example, hospitals and Academic Medical Centers (AMC), load clinical data into HSN. They have administrative and user management privileges to grant access to third party institutions within the network for protocol validation and patient recruitment activities using their data.
Protocol Validator Cloud Service (PV): Lets customers, for example, pharma, medical device, AMCs, perform modeling, feasibility, and validation of their clinical study protocols leveraging data from third party DM customers in the network.
Patient Recruiter Cloud Service (PR): Lets existing PV customers, for example, Pharma, AMCs, share their validated protocols with the respective third party DM customer to initiate real time, patient recruitment activities.

1.2 What's New

In release 2.0.1, each protocol is created for a single provider only and run against that provider for validation, analysis and recruiting. You can now create one protocol per partner, selecting the partner while creating the protocol. There is no need for a network count query, which requires the ability to run the same criteria query against multiple providers. You do not have to select a provider for validation, analysis or recruitment actions. Also, there is no step to initiate validation—each protocol begins in Validation.

To support criteria finding genes and mutations, an omics lite feature is included as a top level criteria in inclusion and exclusion. A sponsor using a protocol for a partner that supports and offers omics service, can select one or more genes or mutations to add to the top level of inclusion or exclusion criteria. A sponsor can view gene and mutation criteria in the criteria editor, and analysis (if offered by provider). Providers can also configure relationships to offer omics services to selected sponsors as a service. However, providers cannot set maximum protocols or data restriction.

1.3 What Can I Do Using Oracle Health Sciences Network?

PVPR application services lets users define, save and share protocols to identify cohorts of patients that match a protocol's criteria. It provides workflow features, to help users review the feasibility of protocol definitions as well as validate discreetly identify qualified patients appropriate for study recruitment. An organization using HSN may request and receive information from one or more other organizations participating in the network.

The HSN platform establishes a scalable framework that supports multiple participant organizations and service relationships providing significant value by eliminating the current constraint of distinct dedicated data environments.
Introduces more flexible opportunities for collaboration and revenue because the platform will support the definition of discreet usage agreements. For example, along with unlimited data access, a participant organization can contract to participate based on a number of protocols, or querying a specific therapeutic area, meaning a diagnostic grouping like Oncology related data.
A protocol is not restricted to a specific owner, but can have multiple users from the same partner working on it as a team (that is, to support peer review or internal approval processes before sharing the definition for recruitment.
Ability for the protocol team to query patients across one or more DM Partners, and also share the approved protocol with one or more Data Management (DM) Partners for recruitment.
Ability for DM Partner users to review the protocol's list of candidates (matched patients) and subsequently refine who qualifies and is appropriate to enroll in the study.

Following are the activities that can be performed using HSN PVPR:

Table 1-1 PVPR Functions

Service	Business Process	Sponsor	DM Partner
Protocol Validator (PV) Create and define a protocol and its eligibility criteria. Query the network to view matching cohort counts (gauge feasibility of the protocol). Refine protocol Criteria to make it feasible. Send the protocol to one or more partners as a request for recruitment.	Create and Define a Protocol Edit a Protocol Delete a Protocol Gauge feasibility of the Protocol (execute queries and view counts)	Registered to make validation requests	Registered to provide validation responses
Patient Recruiter (PR) View Recruitment Requests (protocol details and matched patient information in order to validate and enroll patients in a study. Update patient status (for example, qualified, enrolled, excluded), based on review of patient data and protocol definition. Monitor progress towards target recruitment counts. Initiate and stop recruitment activities.	Monitor Recruitment Requests Accept Recruitment Requests Identify and Qualify Patients Identify Patients for Enrollment into Trial Monitor Protocol Recruitment Status and Progress over Time Stop or Cancel Recruitment	Registered to make recruiting requests (share protocols for recruitment)	Registered to receive and act on recruitment requests

Service

Business Process

Sponsor

DM Partner

Protocol Validator (PV)

Create and define a protocol and its eligibility criteria.
Query the network to view matching cohort counts (gauge feasibility of the protocol).
Refine protocol Criteria to make it feasible.
Send the protocol to one or more partners as a request for recruitment.

Create and Define a Protocol
Edit a Protocol
Delete a Protocol
Gauge feasibility of the Protocol (execute queries and view counts)

Registered to make validation requests

Registered to provide validation responses

Patient Recruiter (PR)

View Recruitment Requests (protocol details and matched patient information in order to validate and enroll patients in a study.
Update patient status (for example, qualified, enrolled, excluded), based on review of patient data and protocol definition.
Monitor progress towards target recruitment counts.
Initiate and stop recruitment activities.

Monitor Recruitment Requests
Accept Recruitment Requests
Identify and Qualify Patients
Identify Patients for Enrollment into Trial
Monitor Protocol Recruitment Status and Progress over Time
Stop or Cancel Recruitment

Registered to make recruiting requests (share protocols for recruitment)

Registered to receive and act on recruitment requests